De Novo · Granted
GrantedVysis Autovysion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vysis · NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
Granted on Dec 13, 2004 as a new device type through De Novo after a 61-day review. 8 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- NTH
- Recalls
- None
8 later devices descend from it, 3 citing it directly.
- This deviceDEN040010 Vysis Autovysion SystemVysis · 2004
- Descendant · cites it directly · 7 of its ownK050840 Modification to Duet SystemBioview, Ltd. · 2005
- Descendant · cites it directly · 5 of its ownK061602 Duet SystemBioview, Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK101291 Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK110345 Scanview SystemApplied Spectral Imaging · 2011
- Descendant · 2 generations on · 0 of its ownK130775 Duet SystemBioview, Ltd. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050840Modification to Duet SystemBioview, Ltd. · 2005 · cites it directly7descendants
- K061602Duet SystemBioview, Ltd. · 2007 · cites it directly5descendants
- K101291Scanview HER2/Neu Fish SystemApplied Spectral Imaging, Ltd. · 2010 · 2 generations on2descendants
- K110345Scanview SystemApplied Spectral Imaging · 2011 · 2 generations on1descendant
- K130775Duet SystemBioview, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040010 | Vysis Autovysion System | Vysis | 2004 | — |
| +1 | K050840 | Modification to Duet System | Bioview, Ltd. | 2005 | — |
| +1 | K061602 | Duet System | Bioview, Ltd. | 2007 | — |
| +2 | K101291 | Scanview HER2/Neu Fish System | Applied Spectral Imaging, Ltd. | 2010 | — |
| +2 | K110345 | Scanview System | Applied Spectral Imaging | 2011 | — |
| +2 | K130775 | Duet System | Bioview, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NTH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050840 (Bioview, Ltd., 2005) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NTH devicesNTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTH
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NTH
Too few NTH 510(k)s in any year since 2007 to give a median.
Recalls per year · NTH
No recall names NTH since 2007.
Adverse event reports per year · NTH
1in 2024
MAUDE reports naming product code NTH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN040010 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN040010: Vysis Autovysion System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN040010
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026